ECOLAB
Received Apr 6, 2016 · Event occurred Mar 11, 2016
Report 1047429-2016-00009 · MDR key 5551414
Product problems
- Hole In Material
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
AVID MEDICAL IS THE MANUFACTURER OF A CUSTOM PROCEDURE TRAY THAT CONTAINS A WARMER DRAPE PART # ORS-300N MANUFACTURED BY(B)(4). AVID MEDICAL RECEIVED A COMPLAINT ON (B)(6) 2016 ORIGINATED BY (B)(6), STATING A HOLE IN THE WARMER DRAPE WAS DISCOVERED AT THE END OF THE CASE. THE DRAPE INVOLVED IN THE COMPLAINT WAS NOT AVAILABLE FOR EVALUATION. AVID MEDICAL ISSUED FORMAL COMPLAINT #(B)(4) TO THE MANUFACTURER (B)(4) FOR A HOLE IN THE WARMER DRAPE - PART # ORS-300N. THE WARMER DRAPE LOT # D152591; D151901RHVO. NO PATIENT INJURY WAS REPORTED.